Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tuta Healthcare Pty Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023595 | BURETTE-IN LINE (150 ML) | Tuta Healthcare Pty Limited | 2002-12-18 | 51 | 0 |
| K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | 2002-11-07 | 56 | 0 |
| K020083 | TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 | Tuta Healthcare Pty Limited | 2002-02-12 | 33 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda